Forced degradation and impurity profiling: Recent trends in analytical perspectives

被引：129

作者：

Jain, Deepti ^{[1
]}

Basniwal, Pawan Kumar ^{[1
,2
]}

机构：

[1] Rajiv Gandhi Technol Univ, Sch Pharmaceut Sci, Bhopal 462033, Madhya Pradesh, India

[2] LBS Coll Pharm, Jaipur 302004, Rajasthan, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2013年 / 86卷

关键词：

Impurity; Forced degradation profiling; Analytical perspectives; active pharmaceutical ingredient; Drug products; PERFORMANCE LIQUID-CHROMATOGRAPHY; ACTIVE PHARMACEUTICAL INGREDIENT; INDICATING HPLC METHOD; RESPONSE FACTOR DETERMINATION; TANDEM MASS-SPECTROMETRY; STRUCTURAL ELUCIDATION; LC-MS; POTENTIAL IMPURITIES; STRESS DEGRADATION; DRUG SUBSTANCE;

D O I：

10.1016/j.jpba.2013.07.013

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were discussed on the head of year of publication; columns, matrix (API and dosage forms) and type of elution in chromatography (isocratic and gradient); therapeutic categories of the drug which were used for analysis. It focuses distinctly on comprehensive update of various analytical methods including hyphenated techniques for the identification and quantification of thresholds of impurities and degradants in different pharmaceutical matrices. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：11 / 35

页数：25

共 207 条

[1]

Abbas S.S., 2012, B FAC PHARM CAIRO, V50, P49, DOI DOI 10.1016/J.BFOPCU.2012.02.001

[2]

Ahuja S., 2003, HDB ISOLATION CHARAC

[3]

Ahuja S., 1998, IMPURITIES EVALUATIO, P42

[4] Development and validation of an analytical method for metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations by HPLC-UV [J].

Al-Rimawi, F. .

TALANTA, 2009, 79 (05) :1368-1371

[5] Evaluation of mobile phase gradient supercritical fluid chromatography for impurity profiling of pharmaceutical compounds [J].

Alexander, A. J. ;

Hooker, T. F. ;

Tomasella, F. P. .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2012, 70 :77-86

[6] The role of degradant profiling in active pharmaceutical ingredients and drug products [J].

Alsante, Karen M. ;

Ando, Akemi ;

Brown, Roland ;

Ensing, Janice ;

Hatajik, Todd D. ;

Kong, Wei ;

Tsuda, Yoshiko .

ADVANCED DRUG DELIVERY REVIEWS, 2007, 59 (01) :29-37

[7]

Annapurna M Mathrusri, 2012, J Pharm Anal, V2, P466, DOI 10.1016/j.jpha.2012.06.003

[8] Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection [J].

Arayne, M. Saeed ;

Sultana, Najma ;

Siddiqui, Farhan Ahmed ;

Mirza, Agha Zeeshan ;

Qureshi, Faiza ;

Zuberi, M. Hashim .

JOURNAL OF CHROMATOGRAPHIC SCIENCE, 2010, 48 (07) :589-594

[9] Liquid chromatographic analysis of oxytocin and its related substances [J].

Ashenafi, Dunge ;

Van Hemelrijck, Elise ;

Chopra, Shruti ;

Hoogmartens, Jos ;

Adams, Erwin .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2010, 51 (01) :24-29

[10] Isolation and structural elucidation of two impurities from a diacerein bulk drug [J].

Ashok, Chaudhari ;

Golak, Maikap ;

Adwait, Deo ;

Krishna, Vivek ;

Himani, Agrawal ;

Umesh, Peshawe ;

Amol, Gawande ;

Srinivas, Sompalli ;

Sharad, Mane ;

Deepali, Jadhav ;

Atul, Chauldhari .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2009, 49 (02) :525-528

← 1 2 3 4 5 6 7 8 9 10 →